Shivering and Glucose Homeostasis

Maastricht University

Status: Completed

Conditions: Healthy Overweight/Obese

Treatments: Other: Cold exposure

Study type: Interventional

Funder types: Other

Identifiers

NCT04516018

NL73487.068.20

Details and patient eligibility

About

The purpose of this study is to investigate the effect of prolonged shivering thermogenesis on glucose homeostasis in overweight/obese humans.

Enrollment: 15 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent
• Caucasian
• Healthy (as determined by dependent physician based on medical questionnaire)
• Man, or postmenopausal (defined as at least 1year post cessation of menses) woman
• Aged 40 - 75 years at the start of the study
• BMI 27 and 35 kg/m2
• Stable dietary habits (no weight loss or gain >3kg in the past 3 months)

Exclusion criteria

• • Not meeting all inclusion criteria
• Medication use known to hamper subject's safety during study procedures
• Co-morbidities to which the intervention or program that may pose as a complicating factor
• Subjects diagnosed with cardiovascular diseases or cancer
• Fasting plasma glucose ≥ 7.0 mmol/l
• Haemoglobin < 7.8 mmol/l for women, or < 8.4 mmol/l for men
• Previously diagnosed with type 2 diabetes
• Abuse alcohol/drug abuse
• Subjects who do not want to be informed about unexpected medical findings during the screening/study or do not wish that their physician is informed.
• Engagement in structured exercise > 2h per week
• Participation in another biomedical study within 1 month before the first study
• Smoking
• Cold-acclimated, such as takes daily extended cold baths, works in a refrigerated environment, or regular cold-water swimming within 1 month of starting the study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Cold acclimation arm

Experimental group

Description:

An oral glucose tolerance test will be performed on day 1 of the study. The next day (day 2), subjects will be exposed to shivering thermogenesis for at least 1 hour. The day after, an oral glucose tolerance test will be performed (day 3). The following 9 days, subjects will be exposed daily to shivering thermogenesis for at least 1 hour (day 4-12). On the last day (day 13), an oral glucose tolerance test will be performed.

Treatment:

Other: Cold exposure